Atopic Dermatitis
Conditions
Brief summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
Detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.
Interventions
DRUGAK120
300mg Q2W subcutaneous injection thereafter until week 50.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged ≥18≤75 years old. 2. Atopic dermatitis (AD) diagnosed at least 1 year before screening. 3. Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline. 4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
Exclusion criteria
1. Acute onset of AD within the first 4 weeks of randomization. 2. Have participated in any clinical research on AK120 in the past 3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization. 4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer) 5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period. 6. Received allergen specific immunotherapy within the 3 months before randomization. 7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 | at week 16 | Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA | at week 16 | The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16. |
Countries
China
Contacts
Primary ContactGuoqin Wang
Outcome results
None listed